For more than two years prior to the subject invention free sugar had been used on wounds either as a single constituent or in conjunction with povidone-iodine (Betadine.RTM. solution). During this period sugar was poured directly into the wound (if the wound was deep), a 4-inch (10.16 centimeters) by 4-inch sponge or other dressing material was soaked in Betadine.RTM. solution and used to dress the wound and the dressing was changed at intervals of from 6 to 8 hours; shallow wounds were dressed with Betadine.RTM. solution-soaked sponges which were then coated with approximately 0.25 inch (0.635 centimeter) of sugar and applied face down (sugar in direct contact with the wound) to the wound.
Notwithstanding handling difficulties and lack of control or uniformity, wound-healing time was markedly reduced in this manner. In more than 300 cases such use of povidone-iodine solution in conjunction with sugar proved to be a safe, reliable and rapid method for healing of a variety of wounds. These wounds included both clean and infected, fresh and old wounds. Their variety extended from simple abrasions and lacerations to massive soft tissue trauma, including burns, crush injuries, shot-gun and gun shot wounds; decubitus, diabetic and stasis ulcers; and exposed, fractured bone.
In massive soft tissue injuries (such as shot-gun wounds and second- or third-degree burns) debridement was essential as in routine wound care. Thereafter, repeated dressing changes with sugar and povidone-iodine solution were found to produce a clean, granulating wound in rapid fashion, with no production of eschar and no superficial infection, despite the absence of systemic antibiotics.
Surprisingly, this treatment produced large amounts of granulation tissue in quantities sufficient to fill in large soft-tissue defects secondary to the original wound. Skin rather rapidly covered the new, exuberant granulation tissue spontaneously, thereby largely reducing healing time and the necessity for skin grafting.
Regeneration of tissue, rather than retraction of the wound, was the general rule. In many cases the healed wound was soft and resilient, with good sensation.
There is good evidence to suggest that sugar products, such as honey and molasses, were used in treating wounds, including burns, in ancient times. Evidence suggests that the native American Indians from Canada to the Inca Empire were adept in the use of a number of medicinal compounds which showed considerable promise in the treatment of wounds and burns. These included herbs, root extracts, leaf extracts and varieties of maple syrup, sorghum, molasses, honey and eventually sugar (as sugar cane). In ancient Egypt, preservation of food and treatment of wounds included the use of sugar products.
Povidone-iodine (polyvinylpyrrolidone-iodine complex) is a topical anti-infective ("The Merck Index", ninth edition, pages 996 and 997, entry 7499, Merck & Co., Inc., 1976) which is commercially available in a number of forms, e.g., Betadine.RTM. antiseptic gauze pad, solution, solution swab aid, aerosol spray, surgical scrub, douche, vaginal gel, skin cleanser, ointment, microbicidal bath, perineal wash and whirlpool concentrate [Physicians' Desk Reference" (PDR), 31st edition, pages 1263 to 1265, 1977].
Typical formulations for PVP-I products, such as Betadine.RTM. solution (1000 liters) and Betadine.RTM. ointment (one pound), are:
______________________________________ PVP-I Solution (a) PVP-I Powder 125 kg (b) Sodium Phosphate (tribasic) 7.5 kg (c) Triton X-114 4.0 kg (d) Water (q.s.) 1000 liters (Triton X is polyethylene glycol p-isooctylphenyl ether) Analysis (a) pH: Less than 6.0 (b) Density: 1.03 to 1.04 (c) Viscosity: 15 to 25 cp (d) Superficial Tension: 31 to 33 dynes/cm (e) Available Iodine: 1.15-1.20% PVP-I Ointment (a) PVP-I Powder 45.5 g (b) PEG 400 (Carbowax) 272.4 g (c) PEG 4000 (Carbowax) 113.5 g (d) Water (q.s. one pound) 22.7 g Analysis (a) Viscosity at 70.degree. C. 18,000 to 22,000 cp (b) Available Iodine 1.05 to 1.13% ______________________________________